Director, Global Regulatory Affairs, Inflammation Autoimmune, Infection and Vaccines
Regulatory Affairs Director
Feel valued for your influential work in shaping drug development and gaining fast, efficient approvals. We are pro-actively involved in the strategy, changing the course for approvals and influencing regulators on new technology. Without us, our ground-breaking science wouldn’t have half the impact.
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being results-oriented thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
AstraZeneca’s pipeline of innovative medicines is consistently growing within Regulatory Science, Inflammation Autoimmune, Infection and Vaccines one of our major therapy areas. To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of strategically focused Regulatory Affairs professionals . With us, you will get the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across multiple therapy areas in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.
We continue to expand our regulatory teams at AstraZeneca’s dynamic R&D sites in Gothenburg, Sweden, Cambridge, UK, Gaithersburg, US and Durham, US. If you are looking for a new challenge, we are offering opportunities in different disease areas and at different levels, depending on your expertise and previous experience.
Main duties and responsibilities
As a Regulatory Affairs professional within AstraZeneca, you will play a key role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs. In this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world.
Strategic thinking is key within our function. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
In combination with your regulatory expertise, successful candidates will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. It is important that you embrace the concepts of novel regulatory tools and technology as well as a culture of sharing experiences with others so that the medicines that we develop will benefit from latest approaches in regulatory science. You are comfortable speaking the regulatory voice at all levels of the organisation.
Academic degree in a science related field or equivalent
Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development
Proven track record of regulatory drug development including product approval/launch.
Successful leadership to at least one major regulatory approval at a global level is required for senior positions.
Experience in leading Major Health Authority interactions
Ability to think strategically and critically and evaluate risks to regulatory activities.
Ability to work strategically within a complex, business critical and high-profile development program.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you! Welcome with your application (CV and cover letter) no later than 31 October, 2021.
We will review the applications continuously so please apply as soon as possible.
Read more about a career within Regulatory Affairs at AstraZeneca:
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.